Clinical Benefits of B-Flow Ultrasound

University of Washington

Status: Completed

Conditions: Hypertension; Evidence of Liver Transplantation; Arterial Occlusive Diseases; Pregnancy, High Risk; Pregnancy

Treatments: Device: GE LOGIQ E9 Ultrasound System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02008097

45374

Details and patient eligibility

About

The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ E9 system in three clinical focus areas.

1. Liver transplant patients: Improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty.
2. Renal artery disease: Improved real-time visualization of the renal arteries would enable a more rapid and accurate assessment of renal artery disease (stenosis, dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery interventions.
3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta perfusion and assay for potential ischemia.

Enrollment: 180 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must be referred for a standard clinical ultrasound exam.

• Patients who have had a Liver Transplant and are referred for a liver ultrasound or angioplasty & stent placement;
• Patients with hypertension, impaired renal function, or renal artery disease who are referred for a renal ultrasound or angioplasty & stent placement;
• Pregnant women referred for an obstetrical ultrasound to evaluate a normal pregnancy for example to determine gestation or gestational age;
• Pregnant women referred for an obstetrical ultrasound to evaluate a high risk pregnancy due to a medical condition present before or during pregnancy for either the mother or the baby.

Exclusion criteria

• Minors;
• Prisoners;
• Unable to understand the nature of the study or to consent;
• Very sick or experiencing significant pain;
• Undergoing an emergency ultrasound;
• Pregnant and undergoing an ultrasound to evaluate suspected congenital malformation, abruptio placenta or fetal death.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 6 patient groups

Liver transplant without a stent

Experimental group

Description:

Liver Transplant patients without a stent who are referred for liver ultrasound will have will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System .

Treatment:

Device: GE LOGIQ E9 Ultrasound System

Liver transplant with a stent

Experimental group

Description:

Liver transplant patients who are referred for angioplasty and stenting, or who have had angioplasty and stenting and are referred for liver ultrasound will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.

Treatment:

Device: GE LOGIQ E9 Ultrasound System

Renal artery disease without a stent

Experimental group

Description:

Patients with hypertension or impaired renal function who are referred for renal ultrasound will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.

Treatment:

Device: GE LOGIQ E9 Ultrasound System

Renal artery disease with a stent

Experimental group

Description:

Patients who are referred for angioplasty and stenting, or who have had angioplasty and stenting and are referred for renal ultrasound will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.

Treatment:

Device: GE LOGIQ E9 Ultrasound System

Pregnancy, Normal

Experimental group

Description:

Pregnant women referred for an obstetrical ultrasound to evaluate a normal pregnancy; for example, to determine gestation or gestational age will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System.

Treatment:

Device: GE LOGIQ E9 Ultrasound System

Pregnancy, High Risk

Experimental group

Description:

Pregnant women referred for an obstetrical ultrasound to evaluate a high risk pregnancy due to a medical condition present before or during pregnancy for either the mother or the baby will have a B-Flow ultrasound exam using the GE LOGIQ E9 Ultrasound System. Examples of risk factors include placenta previa, vaginal bleeding, suspected multiple gestation, suspected uterine abnormality, suspected fetal growth abnormality, advanced maternal age, a prior C-section, prior low birth weight baby, and prior preterm birth.

Treatment:

Device: GE LOGIQ E9 Ultrasound System